Pacemakers Without Silastic Coating

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K790764 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of this pacemaker, and who should consider using it?

  This pacemaker is designed to regulate abnormal heart rhythms, specifically for patients diagnosed with bradycardia or other conduction disorders requiring chronic cardiac pacing. It delivers consistent electrical impulses to maintain proper heart function, ensuring a stable pacing rate. Clinicians should consider it for patients who need reliable, long-term pacing support in a controlled clinical setting.

• Is this device intended for reuse, or is it meant to be implanted as a single-use device?

  This pacemaker is explicitly intended for single-use implantation. It is supplied sterile and does not require additional sterilization or reprocessing after use, as it is meant to remain implanted permanently once placed by trained medical professionals.

• What distinguishes this pacemaker from others, and why might that matter to a clinician?

  This pacemaker is notable for its lack of a Silastic coating, which may influence biocompatibility or patient response. Clinicians might consider this feature if they are evaluating potential complications related to material interactions, though the primary function remains consistent pacing for bradycardia or conduction disorders.

• How should this device be stored before implantation, and what precautions should be taken?

  Since the device is supplied sterile, it should be stored in its original packaging until ready for use to maintain sterility. It must be implanted in a controlled clinical setting by trained professionals, as it is not designed for reprocessing or reuse. Proper handling and adherence to sterile techniques are critical before implantation.

• What regulatory pathway was followed for this device, and how does that affect its use?

  This pacemaker was cleared through the FDA’s 510(k) process under the Cardiovascular advisory committee, with a decision of